Locemia: A Glucagon Nasal Spray to Replace Complex Injections

Everyone who has a loved one taking insulin knows the fear of low blood sugar so severe that they become non-responsive or unconscious. There is enormous pressure to get their blood sugar up quickly, and the only solution (for someone without access to an IV) is glucagon.

Glucagon is a hormone that tells the liver to dump sugar into the bloodstream. In ten minutes, it can raise the blood sugar over 200 mg/dL (10 mmol). Until now, delivering glucagon has been a complex and stressful process of mixing a solution and injecting it (see below). But now that is about to change.

After years of working in secret, the team at Locemia announced that they have made a dramatic advance in glucagon delivery technology. The mixing and injecting process has been replaced by a simple nasal spray. The product has already completed Phase 3 clinical trials and will be submitted for FDA approval by the end of this year.

How Glucagon Shots Work Today

To understand how big of an advance Locemia is, look at the frustratingly complex process of giving a glucagon injection. You need to open the container, remove a syringe full of liquid, inject the liquid into a vial of powder, shake the vial to mix combine it, draw the liquid back into the syringe, and inject it into someone.

You typically need to do this all in an adrenaline-filled situation when someone with diabetes is unconscious and non-responsive. Just imagine doing all these steps in an emergency:

It is no surprise that few people are comfortable giving glucagon injections. This means that far too often someone with diabetes can have a severe low blood sugar without anyone around who knows how to help.

Goodbye Shots, Hello Nasal Powder

For Robert Oringer, Co-Creator and Chairman of Locemia, this has been a personal journey. With two teenage boys with diabetes, he wants to be confident that everyone around them is capable of quickly and easily treating them with glucagon.

“There aren’t that many drugs prescribed to someone who won’t use it themselves,” Oringer says. “So ‘make it simple’ has been our whole mantra. It must be needle-free, injection-free, and insanely simple to teach.”

The result is a product that is genuinely easy to use. You put the sprayer to the person’s nose and push down on the plunger. The glucagon spray goes in and sticks to the lining of the nasal passages. It doesn’t matter if the person is conscious or breathing in, it sticks to that lining and is quickly absorbed into the blood.

That’s it. The complex glucagon injection process is replaced by a single, easy step that anyone can do. In their Phase 3 clinical study, the glucagon nasal powder was found to work similarly to the injected glucagon. It took about 15 minutes to work compared to only ten minutes for glucagon – but doesn’t require the complex preparation process.

“It doesn’t matter if breathing in or out – it sticks to the lining of the nasal passage,” says Claude Piché, Co-Creator and CEO. “Whether your are in a coma or seizing, it will just work.”

The long-term goal is to ensure that everyone is able to help anyone who uses insulin. “Our success will be measured by more and more and more people popping up who can help someone using insulin,” says Oringer.

Although there are no official photos of the device – it’s still under development – the folks at diaTribe tweeted out a picture at the recent ATTD conference in Paris:

When Will Locemia Be Available?

The team at Locemia says that they are hoping to file for regulatory approval by the end of 2015. They believe that they can realistically be approved by the end of 2016.

“Our relationships with the FDA has been spectacular,” says Piché. “They’ve been responsive and collaborative.”

Oringer wants it on the market as soon as possible. “I’m sending my son to Croatia for hockey for two weeks soon,” he says. “Can his friends really give him a glucagon injection? I live with this risk, and it hangs over me all the time.”

The speed of Locemia’s development is in large part due to the support of other organizations. “We owe an enormous thanks to the [non-profit] T1D Exchange because they are helping move small companies like ours forward. They serve as our contract research organization. We can recruit faster, access world class researchers. Everything is faster and high-quality.”

“Small companies that have innovative ideas often say it’s too risky to pursue better ideas in type 1,” worries Oringer. “They should call the T1D Exchange and ask how they can work together. I hope we could be a good example of that.”

More Glucagon Advances: Stable Liquids & Micro-Dosing

Locemia is designed to be used in rescue situations. For those who want to prevent or quickly treat a mild low blood sugar, there will soon be other options. Xeris Pharmaceuticals plans on having a micro-dosing glucagon pen on the market within the next two years. You can read about how that works and their plans here.